Compassionate Use of Gemtuzumab Ozogamicin (Mylotarg) for Treatment of Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML) or Acute Promyelocytic Leukemia (APL)
PRIMARY OBJECTIVES:
I. To provide patients with acute myeloid leukemia (AML) or acute promyelocytic leukemia
(APL), who have relapsed or who are refractory to standard treatments, with access to
gemtuzumab ozogamicin (Mylotarg) when no other comparable or satisfactory alternative
therapy is available.
II. To carefully monitor safety and to report safety information from patients receiving
Mylotarg in this setting.
OUTLINE:
Patients receive gemtuzumab ozogamicin intravenously (IV) over 2 hours on days 1 and 15.
After completion of study treatment, patients are followed up every month for 1 year.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Access to gemtuzumab ozogamicin
Up to 1 year
No
Leslie Ellis
Principal Investigator
Comprehensive Cancer Center of Wake Forest University
United States: Food and Drug Administration
CCCWFU# 99213
NCT01869803
June 2013
Name | Location |
---|---|
Comprehensive Cancer Center of Wake Forest University | Winston-Salem, North Carolina 27157-1082 |